Pivoting joint infusion system with seal

ABSTRACT

An infusion system for delivery of therapeutic fluids from a remote source into a patient&#39;s body. The system has an infusion assembly, a rotating pivot joint member, a fluid connector assembly, and a sealing assembly retained within the infusion assembly between the housing of the infusion assembly and the rotating pivot joint member. The seal reduces leakage of fluids. The rotating joint may be pivoted to three distinct positions to allow for emplacement on the patient, delivery of the therapeutic fluid to the patient, and protected, sealed closure of the fluid channels to avoid patient fluid backflow.

This application is a continuation application of continuationapplication Ser. No. 12/952,780, filed Nov. 23, 2010; Ser. No.11/473,254, filed Jun. 22, 2006, now U.S. Pat. No. 7,862,545; Ser. No.10/463,629, filed Jun. 17, 2003, of U.S. patent application Ser. No.09/896,149, filed Jun. 29, 2001, now U.S. Pat. No. 6,579,267, issuedJun. 17, 2003, which claims priority to U.S. Provisional Application No.60/259,971, filed Jan. 5, 2001, all of which are incorporated herein byreference for all purposes.

FIELD OF THE INVENTION

The present invention relates to an improved system for subcutaneousdelivery of fluid to a patient. More particularly, the present inventionrelates to an infusion system having an improved sealing subsystemcooperating with a rotating pivot joint member that delivers the fluidfrom a remote source to a delivery cannula of the main infusion assemblyof the system.

BACKGROUND OF THE INVENTION

Prior art infusion sets or systems provide numerous ways for engaging afluid connector to a base to deliver a therapeutic fluid subcutaneouslyto a patient. Most of these prior art systems are plagued with leakingconnections and inefficient ways to allow the patient to disconnect thefluid connector from the base without a backflow of fluid from thepatient through the base and back into the environment.

The present invention provides an improved sealing subsystemincorporated into a pivoting or rotating “ball” joint that moves from anemplacement position to an infusion or delivery position to adisconnected, protected, closed position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of the present invention systemwith the fluid connector attached to the rotating pivot member in avertical, non-delivery position.

FIG. 2 shows the fluid connection moved to an operating, infusion ordelivery position and locked in engagement with the base unit.

FIG. 3 shows the base unit of the present invention with the rotatingpivot member in the vertical position to accept an emplacement needleassembly.

FIG. 4 is a bottom perspective view of the fluid connector of thepresent invention with a fluid delivery tube attached thereto.

FIG. 5 illustrates a partial cross sectional side elevation plan view ofthe present invention in a first emplacement position. FIG. 5A is across section of the rotating pivot joint member.

FIG. 6 shows the pivot member and base unit of FIG. 5 with theemplacement needle withdrawn and the rotating pivot member rotated to asecond infusion or delivery position.

FIG. 7 is an exploded perspective view of the base unit of the presentinvention showing the seal assembly and the rotating pivot member.

FIG. 8 is a detailed perspective view of the seal assembly of thepresent invention.

FIG. 9 illustrates a perspective view of the base assembly and therotating pivot member of the present invention rotated to a protectedclosed position to prevent backflow of patient fluids.

FIG. 10 shows three distinct positions of the rotating or pivotingmember of the present invention, namely, the emplacement position, theinfusion position, and the protected, closed position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE PRESENTINVENTION

FIG. 1 is a perspective view of the infusion system 10 of the presentinvention. In FIG. 1, the main infusion unit 12 is shown with the fluidconnector assembly 14 attached to the rotating pivot joint member 16.The joint member 16 is rotatably attached to the housing 17 of unit 12.The emplacement needle 18 (FIG. 5) has been withdrawn and the connectorassembly is still in an upright or vertical position. Therapeutic fluidfrom a remote source (not shown but well known in the art) such as awall or rack hung bottle or plastic fluid bag may be delivered throughdelivery tube 20 to the connector assembly 14 and into the patient.However, the preferred procedure is for the needle to be withdrawn andthe joint member 16 slightly rotated downwardly to misalign theemplacement channel 54 (FIG. 5A) and the injection channel 40. This willprevent or significantly avoid a backflow of patient fluids as will bediscussed below. The connector assembly 14 is then attached to the jointmember 16 and the rotating joint member and the connector assembly 14are to be rotated about joint member 16 to the horizontal delivery orinfusion position shown in FIG. 2. In FIG. 2, the fluid connector 14 hasrotated about joint 16 and has locked onto the locking tabs 22 (FIG. 1)of the main infusion unit 12 and is thereby held securely in place.

FIG. 3 shows a slightly modified main infusion unit 12 a having a pivotjoint member 16 a with an 0-ring seal 24 on neck section 26 of thejoint. Neck 26 has opposing wings 28 which serve to ensure an alignedrotation of the joint 16 a about the housing 17 a. The wings furtherfunction to ensure proper alignment of the connector assembly 14 a tothe main infusion unit 12 a. FIG. 9 additionally shows how wings 28 holdthe neck 26 in a third distinct position. FIG. 3 also illustrates arecess section 30 and cover 32 in housing 17 a. As will be describedbelow, the recess 30 accepts the top section of neck 26 in a thirdrotated position of joint 16 a and cover 32 shields, protects, and sealsthe central fluid channel 34 in the joint member 16 a when the fluidconnector has been removed from the rotating pivot joint member 16 a.

FIG. 4 illustrates in a perspective view the underside or bottom side ofthe fluid connector 14 a which attaches at a near end 36 to the rotatingpivot joint member. It should be noted in FIG. 4 that the fluid deliverychannel 38 in connector 14 a has a slight approach angle variation aswill be described in more detail in the discussion of FIG. 10.

The structural arrangement or relationship of the joint member 16 a tohousing 17 a is seen in the partial cross sectional view of FIG. 5. FIG.5 shows the joint 16 a in a first emplacement position with anemplacement needle 18 extending through the rotating joint 16 a, throughthe injection channel 40 of cannula 42, and subcutaneously piercing theskin of the patient. A retainer plate 44 holds the cannula 42 within thehousing 17 a. The emplacement of the needle 18 and how the main infusionunit may be affixed to the patient are well understood as described inU.S. Pat. No. 6,579,267. Also shown in FIG. 5 is the placement andretention of sealing assembly 50 within housing 17. FIG. 8 shows thesealing assembly in greater detail.

The rotating pivot joint member 16 a is shown in a side elevationalcross sectional view in FIG. 5A. Central fluid channel 34 with alongitudinal axis 34 a, needle emplacement channel 54, and fluidinfusion channel 56 intersect in a central portion 58 of the joint 16 a.Grooves 62 are provided for O-ring seals in the neck section.

FIG. 6 shows the pivot member or joint 16 a with the emplacement needle18 withdrawn and fluid connector assembly 14 a attached. The joint 16 ais rotated to an infusion or delivery position with the infusion channel56 aligned with the injection channel 40 in cannula 42. Thus,therapeutic fluid 60 from the remote source flows through fluid deliverychannel 38 in connector assembly 14 a into central fluid channel 34,into infusion channel 56 through cannula injection channel 40 into thepatient. As would be understood by one of skill in the art, theconnector assembly 14 a is secured to the main infusion unit 12 a by thelocking tabs 22 a urging against the body 15 of the connector assembly.

In FIG. 7 an exploded perspective illustration is provided of pivotjoint member 16, housing 17, sealing assembly 50, and rotating pivotjoint member receiving chamber 51. The joint 16 has axial rotationjournals or ears 72 which engage in slots 70 in the receiving chamber51. The sealing assembly also fits snugly between the housing 17 and thejoint 16 when the system is fully assembled. Turning to FIGS. 5 and 6 itmay be seen that elastomeric seal 50 is urged beneath overhanging ledge53 of housing 17 and is thereby further held in position. When the joint16 is rotatably secured in the chamber 51, the seal 50 provides asealing surface for the joint 16 to sealingly rotate upon. In FIG. 8,the L-shaped seal assembly 50 has an orifice 61 to allow the needle orfluid to pass through. A raised rib 80 along the inner surface 81 of theseal may be used to provide an additionally tight seal. It should beunderstood that the use of various cooperating materials may be used inthe construction of the seal 50 and the joint 16. A hard-to-soft surfaceinterface may be employed. The seal may be softer than the joint or viceversa. Two hard surfaces with cooperating coefficients of friction maybe employed.

A protected, closed, and sealed third position of the rotating pivotjoint member 16 a is shown in FIG. 9. When the patient removes theconnector assembly 14 or 14 a from the pivot joint 16 or 16 a, thealignment of the injection channel and the infusion channel in the jointwould allow patient fluids to flow back through the infusion assemblyand leak or flow into the environment. However, a unique feature of thepresent invention allows the user to rotate the pivot joint 16 adownwardly to a third distinct position placing the neck 26 and centralfluid channel 34 into recess 30 with cover 32 sealing off the openchannel 34. Thus, no patient fluids backflow through the system. FIG. 9also illustrates that alignment wings 28 also function to stop thedownward rotation of the joint 16 a; and, because they rub or slidetightly along housing shoulder 27 of the main infusion assembly 12 a,the neck 26 is retained in the recess during the user's movement.

The distinct positions of the rotating “ball” pivot joint member 16 areillustrated in FIG. 10. In position A, the emplacement needle may beguided through the appropriate channels in the joint to allow the maininfusion unit 12 to be attached to the patient. In position B, theneedle has been removed and the fluid connector assembly 14 attached tothe joint 16. The fluid channels in the connector assembly and the jointare aligned to allow for the therapeutic fluid to flow from the remotesource through the delivery tube, through the joint and cannula channelsto the patient. In position C, the fluid connector assembly 14 has beenremoved and the joint rotated further downwardly to rest in recess 30with cover 32 sealing the fluid channel 34. Additionally, the furtherrotation of the joint misaligns the infusion channel 56 of the jointfrom the injection channel 40 of the cannula thereby further sealing offthe backflow of any patient fluids through the system to theenvironment.

It may be seen in FIG. 10 that the sealing assembly 50 directly engagesover 90° of the surface of the pivot joint 16 in any one of the distinctpositions; but, because of the rotatability of the joint, over 270° ofthe ball joint surface is sealingly urged against the seal assembly 50.This feature provides for a more efficient sealing of the channels inthe joint thereby reducing leakage problems associated with the priorart.

Although the invention has been described with reference to a specificembodiment, this description is not meant to be construed in a limitingsense. On the contrary, various modifications of the disclosedembodiments will become apparent to those skilled in the art uponreference to the description of the invention. It is thereforecontemplated that the appended claims will cover such modifications,alternatives, and equivalents that fall within the true spirit and scopeof the invention.

The invention claimed is:
 1. A device for subcutaneous delivery of a therapeutic fluid from a remote source into a patient's body, the device comprising: an infusion assembly having a generally flat lower surface with a cannula, the cannula depending downward from the lower surface and, in use, extending subcutaneously into skin of the patient; a rotating joint assembly having a fluid channel therein, the fluid channel having a first channel portion with a first opening in a first portion of the rotating joint assembly and a second channel portion with a second opening in a second portion of the rotating joint assembly, the first and second channel portions angled with respect to one another and connected so that therapeutic fluid may flow between the two openings; wherein the infusion assembly and the rotating joint assembly may be engaged such that the rotating joint assembly may move from a non-delivery position, where a longitudinal axis of the first channel portion is in a position non-parallel with the flat lower surface of the infusion assembly, to a delivery position where the longitudinal axis of the first channel portion lays generally parallel to but spaced above the lower surface of the infusion assembly, the delivery position placing the second opening adjacent the cannula and in fluid communication therewith such that therethrough fluid may flow from the first opening through the second opening of the rotating joint assembly and into the cannula of the infusion assembly; and wherein the infusion assembly has at least one locking member to lock the rotating joint assembly in the delivery position.
 2. The device according to claim 1, further comprising: a connector assembly attached to the rotating joint assembly; and wherein the at least one locking member of the infusion assembly comprises locking tabs that cooperate with the connector assembly to lock the rotating joint assembly in the delivery position.
 3. The device according to claim 2, wherein the locking tabs are urged against a body of the connector assembly to lock the rotating joint assembly in the delivery position.
 4. The device according to claim 1 wherein, when the rotating joint assembly is in the non-delivery position, an emplacement needle may be extended through the first channel opening, through the first channel portion, and through an injection channel of the cannula to subcutaneously pierce the skin of the patient.
 5. The device according to claim 1, wherein the rotating joint assembly has a needle emplacement channel, and wherein the first channel portion and the needle emplacement channel are aligned with respect to one another and connected so that an emplacement needle may be extended through the first channel opening, through the first channel portion, and through the needle emplacement channel. 